Jiangyin Binjiang Medical Equipment Co., Ltd. · 89-08 · CHINA
For Jiangyin Binjiang Medical Equipment Co., Ltd., import alert is 89-08; country is CHINA; import alert name is "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"; product is Portable Electric Steam Sterilizer (Model SYL-280B); product code is 80 F - - LE Sterilizer, Steam; date published is 09/19/2011; address is Eastern Area of Chengjiang Town , Industrial Park , Jiangyin City, CHINA, verified against its source on 2026-09-30.
- Firm
- Jiangyin Binjiang Medical Equipment Co., Ltd. verified
- Import alert
- 89-08
- Import alert name
- "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"
- Country
- CHINA verified
- Address
- Eastern Area of Chengjiang Town , Industrial Park , Jiangyin City, CHINA verified
- Date published
- 09/19/2011 verified
- Product code
- 80 F - - LE Sterilizer, Steam verified
- Product
- Portable Electric Steam Sterilizer (Model SYL-280B) verified
- FDA notes
- Class II verified
What the source says
Jiangyin Binjiang Medical Equipment Co., Ltd. Date Published : 09/19/2011 Eastern Area of Chengjiang Town , Industrial Park , Jiangyin City, CHINA
— accessdata.fda.gov, retrieved 2026-09-15
Where each value comes from
The values above are stated away from the sentence quoted with the answer, so the passage that states them is shown here too.
Product code, Product and FDA notes
80 F - - LE Sterilizer, Steam Date Published: 09/19/2011 Desc: Portable Electric Steam Sterilizer (Model SYL-280B) Notes: Class II
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html